PHARMExcel’s Quality Policy
Quality in everything we do is integral to all our working practices. It’s critical to the success of our business and our long-term sustainability and profitability.
PHARMExcel is a full-service Contract Research Organisation (CRO) providing Phase I-IV clinical research services to the academic, biopharma and medical device industry. As a leading CRO, PHARMExcel’s collaborative approach, knowledge and experience ensure it delivers quality results in the most efficient way to its clients and partners, regardless of study size or scope. The company offers in-depth knowledge and experience of the UK clinical research industry and has a network of regulatory and other industry associates, enabling a global reach.
PHARMExcel places particular emphasis on reliability and quality. It strives to ensure that its services always meet the needs and satisfaction of its clients in accordance with client, statutory and regulatory requirements and PHARMExcel’s policies and procedures.
PHARMExcel is dedicated to maintaining the Quality Management System (QMS) and in achieving and maintaining ISO 9001:2015 certification. PHARMExcel endeavours continually to improve the effectiveness and implementation of the QMS and satisfy all applicable requirements relevant to the business.
To realise this commitment, PHARMExcel has established the following objectives as a cornerstone of the QMS:
For its clients
- To provide the highest levels of service to its clients.
- To provide confidence to its clients that their requirements for quality are being achieved in the delivered service.
- To work closely with its clients to remedy any quality issues quickly and efficiently.
For the business
- To comply consistently with the requirements of ISO 9001:2015 and all Legal & Statutory requirements by continually seeking to improve the effectiveness of the QMS and overall performance.
- To develop a framework for establishing and reviewing Quality Objectives.
- To provide confidence to management and employees that the requirements for quality are being fulfilled and maintained, and that improvements in quality are continuously being delivered.
- To ensure sufficient resources are made available within the company to achieve this.
- To ensure through communication, engagement, practical examples and training that Quality is the aim of all members of the company.
For its employees
- To maintain a healthy work environment that enables all employees to achieve their objectives and to foster open communication and engagement to encourage employees to raise quality/process improvements.
- To provide continuous training and development for employees in line with both PHARMExcel and employee needs.
- To ensure every employee has a proper understanding of the importance of the Quality System, their responsibility to contribute to its effectiveness, and their accountability to its direct relevance to the success of the company.
- To ensure every employee is responsible for and is fully trained to perform the duties required by their specific role.
To achieve these objectives, it is the policy of PHARMExcel to review the suitability and effectiveness of the QMS and work processes on a consistent basis in conjunction with all managers and employees, whose contribution and input is seen as vital in the improvement and development of PHARMExcel.
The QMS and this policy is seen as essential for the long‐term success of PHARMExcel and will be communicated to all personnel through initial induction, meetings, ongoing development and training to ensure continued adherence and compliance with requirements.
This policy is available to all employees and interested parties:
| Externally | · On the PHARMExcel website |
| Internally
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· As a controlled document in the electronic Quality Management System (eQMS).
· On display in the PHARMExcel office · Upon request from the Quality Assurance department |
This Policy will be regularly reviewed (at least every 2 years) by the Executive Leadership Team (ELT) and amended or added to as appropriate.
POL-0000015 V3.0 24-Sep-2024